Status:
COMPLETED
GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS)
Lead Sponsor:
Genervon Biopharmaceuticals, LLC
Collaborating Sponsors:
Columbia University
Massachusetts General Hospital
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
GM604 is an endogenous human embryonic stage neural regulatory and signaling peptide that controls the development, monitoring and correction of the human nervous system. Neurological diseases are mul...
Detailed Description
Background 1. In the early 1990s Genervon hypothesized that Central Nervous System / Peripheral Nervous systme (CNS/PNS) and rare motoneuron diseases and disorders involve the interplay of a highly c...
Eligibility Criteria
Inclusion
- Patients with ALS: Familial and Sporadic ALS, with symptom onset \< or equal to 24 months.
- At least 18 years of age
- Subjects meet the El Escorial criteria of definite criteria for a diagnosis of ALS.
- Subjects can be on a stable dose of riluzole for at least a month or not taking or initiating riluzole for the duration of the trial.
- Not on any experimental medication for the last 1 month or five times the half-life of experimental medication.
- At screening, must have a Forced Vital Capacity (FVC) ≥ 65% of predicted capacity for age, height and gender.
- Have fully completed informed consent form
- Ability to comply with study procedures
- Women of child-bearing age must be on birth control. Pregnancy test should be done in women in child bearing age.
- Medically safe to have lumbar puncture to collect CSF
Exclusion
- History of liver disease, severe renal failure, diabetes, coronary heart disease, cancer
- Clinically significant EKG abnormality at screening
- Any comorbid condition which would make completion of the trial unlikely
- FVC \< 65%
- Presence of a bleeding disorder
- Allergy to local anesthetics
- Problem with CSF pressure
- Topical or other skin infection at the lumbar puncture site
- BMI \> 32 kg/m2
- Medical or surgical conditions in which a lumbar puncture is contraindicated
- Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin
- \-
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01854294
Start Date
August 1 2013
End Date
July 1 2014
Last Update
April 27 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Columbia Medical Center NY
New York, New York, United States, 10032